Status:
RECRUITING
A Study of GNTI-122 in Adults Recently Diagnosed With T1D
Lead Sponsor:
GentiBio, Inc
Conditions:
Type 1 Diabetes (T1D)
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
This is a 78-week single arm, multi-center, Phase 1 study to evaluate the safety, tolerability, cellular kinetics, and biomarker changes in C-peptide over time of GNTI-122, an investigational cell the...
Detailed Description
This is a 78-week single arm, multi center, Phase 1 study to evaluate the safety, tolerability, cellular kinetics, and biomarker changes in C-peptide over time of GNTI-122 in adult participants with r...
Eligibility Criteria
Inclusion
- Male and female participants aged ≥18 to ≤45 years with recently diagnosed (within 120 days of Screening) T1D according to American Diabetes Association criteria.
- Participant has residual β-cell function during Screening, defined as random C-peptide ≥ 0.2 nmol/L.
- Positive for at least one T1D-associated autoantibody.
- Able and willing to provide written, informed consent as approved by the IRB.
- Is confirmed positive for the HLA-DRB1\*04:01 allele.
- Has adequate vascular access to undergo leukapheresis with no known contraindications.
- 8\. Female participants of childbearing potential must have a negative serum pregnancy test at Screening, must be not lactating, and must agree to protocol-specified contraception.
- 9\. Male participants of childbearing potential must agree to protocol specified contraception.
- 10\. Other than T1D, participant is in good general health.
Exclusion
- Type 2 diabetes.
- Experienced DKA within 4 weeks prior to or during Screening.
- Unwilling or unable to comply with study procedures or schedule.
- Chronic or uncontrolled medical condition.
- Has another active or autoimmune or inflammatory disease with the exception of well-controlled Hashimoto's thyroiditis, celiac disease, or vitiligo.
- Participation in another clinical study or active follow-up in a prior study.
Key Trial Info
Start Date :
September 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06919354
Start Date
September 3 2025
End Date
February 1 2028
Last Update
December 11 2025
Active Locations (9)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
University of California - San Diego
San Diego, California, United States, 92093-0990
3
University of California - San Francisco
San Francisco, California, United States, 94158
4
University of Florida - Gainesville
Gainesville, Florida, United States, 32610